Exhibit 99.1
HedgePath Pharmaceuticals Announces Name Change to INHIBITOR Therapeutics, Inc.
and Ticker Symbol Change to “INTI” Effective August 20, 2019
New Corporate Brand Exemplifies Multiple Near-term Growth Opportunities
Involving Lead Technology, SUBA™- Itraconazole, Inhibiting the Hedgehog Signaling Pathway
INHIBITOR to Hold End of Phase 2 Meeting with FDA in Q4 2019 Prior to Filing IND for Phase 2b
Clinical Trial of SUBA-Itraconazole in Prostate Cancer
INHIBITOR Renews and Expands Exclusive Worldwide Option Agreement with the University of
Connecticut for Novel Compounds that Inhibit Upstream Targets of the Hedgehog Pathway
TAMPA, FL, August 19, 2019 –HedgePath Pharmaceuticals, Inc. (OTCQB:HPPI), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapeutics to inhibit the progression of cancerous andnon-cancerous proliferation disorders, today announced plans to change its name to INHIBITOR Therapeutics as well as a change to the ticker symbol for common and preferred stock to “INTI” from “HPPI.” Both the corporate name change and ticker symbol change are expected to be effective with the opening of trading on August 20, 2019.
In conjunction with the corporate name change, INHIBITOR will launch a new website (www.inhibitortx.com) to showcase INHIBITOR’s vision and development strategy for SUBA-Itraconazole, a proprietary formulation of the FDA approved anti-fungal drug itraconazole designed to enable improved bioavailability compared to conventional itraconazole when used as an anti-cancer treatment, as well as novel compounds that inhibit upstream targets of the Hedgehog Pathway as treatments for cancer andnon-cancerous proliferation disorders.
“Changing our name to INHIBITOR Therapeutics marks an important point of inflection for our company as we are now positioned to capitalize on several business and clinical development initiatives, offering potential catalysts for multiple value-building events during 2019 and 2020,” stated Nicholas J. Virca, President and Chief Executive Officer of INHIBITOR. “In the near-term, following apre-IND (Investigational New Drug) meeting with the Food and Drug Administration (FDA) in April this year, INHIBITOR has secured an End of Phase 2 Meeting (EOP2) with FDA scheduled for the fourth quarter of 2019 to finalize our clinical protocol and statistical analysis plan as we prepare to submit our IND application to study SUBA-Itraconazole in patients with late-stage prostate cancer. Upon IND clearance, we plan to initiate a multi-center, randomized, double-blind, placebo-controlled Phase 2b clinical trial in men with metastatic castrate-resistant prostate cancer (mCRPC) in 2020. Additionally, in 2020, we plan to hold discussions with the FDA to advance our Phase 2b clinical program to study SUBA-Itraconazole in patients with late-stage lung cancer.”
Virca continued, “We are also excited to report the signing of a renewal, for an additional year, of an expanded, exclusive worldwide option agreement with the University of Connecticut to initiatepre-clinical testing in basal cell carcinoma using novel compounds (itraconazole analogues) designed to inhibit specific protein targets of the Hedgehog Pathway. We believe this technology has significant potential and could become a platform for targeting multiple cancerous andnon-cancerous proliferation disorders.”
About SUBA-Itraconazole
SUBA-Itraconazole is a patented formulation of itraconazole designed to enable improved absorption and significantly reduced variability compared to generic itraconazole. Research suggests that these properties offer the potential to provide reduced intra- and inter-patient variability, enable a more predictable clinical dose response, and reduce the active drug quantity required to deliver therapeutic levels into the bloodstream.
